FDA WARNING_LETTER - AFRICANA MARKET LLC - March 11, 2021

On April 29, 2021, the FDA issued a Warning Letter to Africana Market LLC following a remote Foreign Supplier Verification Program (FSVP) inspection conducted from February 9 to March 11, 2021. The inspection, identified by CMS # 614057, found the company non-compliant with section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR part 1 subpart L, which mandates importers perform risk-based activities to verify imported food meets U.S. safety standards.

The primary violation was the failure to develop, maintain, and follow an FSVP for Egusi Seed Paste, Instant Noodles, and Ogbono Nut Meal imported from (b)(4), as required by 21 CFR 1.502(a). The company provided lab analysis reports for these products but did not explain their application to an FSVP, state they constituted an FSVP, or provide records of their review, which the FDA stated do not alone meet the FSVP requirement.

The FDA provided a Form FDA 483a, FSVP Observations, at the inspection's conclusion, but no response was received. Failure to address these violations may lead to refusal of admission for the specified products under section 801(a)(3) of the FD&C Act, potential detention without physical examination (DWPE